efficacy and safety of 1612 capsules in amnestic mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel trial which will be carried out in 15 centers around china. the study population includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both gender. participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per day) or placebo for a 52-weeks double-blind treatment period. the primary outcome measure is change from baseline in the alzheimer's disease assessment scale- cognition subscale (adas-cog) and rate of conversion to dementia. the secondary outcomes are changes from baseline in the mini-mental state examination (mmse), delayed story recall test (dsr), alzheimer's disease cooperative study/activities of daily living scale adapted for mci patients (adcs/mci/adl24). safety is being assessed by observing side effects and adverse reaction during the entire treatment period. statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.


Eligibility criteria:
inclusion criteria: patients should be enrolled if they met the following criteria\[14\]: 1. cognitive complaints from the patients or their families; 2. objective evidence for memory impairment, delayed story recall test(dsr)\<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10); 3. normal general cognitive function, with mini-mental state examination (mmse) score of between 24 and 30 (including 30); 4. preservation of activities of daily living, with alzheimer's disease cooperative study/activities of daily living scale adapted for mci patients (adcs/mci/adl24) score between 38 and 52; 5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5; 6. absence of dementia, not sufficiently impaired cognitively and functionally to meet dsm-iv criteria, 7. enough vision and hearing to accomplishment neuropsychological test; 8. capability to read words and write simple sentence; 9. capability and willingness to give informed consent and to comply with the study procedures. exclusion criteria: the patients would be ineligible if they had the following conditions: 1. non amnestic mild cognitive impairment; 2. meeting the diagnostic criteria for dementia; 3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or aids, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse 4. having significant psychiatric disease, depression, the hamilton depression scale \>12; ct or mri scan showed central nervous system infections infarction or focal lesions within 12 months，the hachinski ischemic scale (his)\>4; 5. combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or copd; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer; 6. used cholinesterase inhibitors or memantine within 1 month; 7. history of hypersensitivity to the treatment drugs; 8. concomitant drugs with the potential to interfere with cognition; 9. administration of other investigational drugs; severe impairment of the functions of the kidney or liver; 10. vegetarians or contraindications for animal innards.